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Terminated

SOMATOM Scope Power, Computed tomography x-ray system

FDA Recall Z-0920-2017 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-11-22
Date Terminated2017-05-30

Reason for Recall

Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connection Box (LCB) to resolve a potential defect that could lead to a power cutout during use of the SOMATOM Scope, Scope Power and Perspective systems.

Firm Action

Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to: IL IL GA SC SD OK NY MI IN MD AR

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K151749somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)Siemens Medical Solutions USA, Inc. · 2016-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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